Category Archives: Law

Continuing the (admittedly sporadic) reports on the AAAS meeting, I wanted to report on a great talk I went to about the Science behind Forensic Science. How accurate is it? I heard a great presentation by three speakers: Anne Marie-Mazza who helped write a report from the National Research Council on Forensic Science, Karen Kafadar, a Statistician from Indiana State, Greg Ridgeway, the Acting Director for the National Institute of Justice, which is the Science part of the Department of Justice (they also investigate things like body armor). I was excited before I even went to the talk because I had heard of the CSI effect in which juries essentially think that evidence should be like in those crime shows. I knew there were lots of inaccuracies on the forensics shows on tv. (For instance, why would people all work in the dark or green light? Turn on the light!) What I didn’t realize, however, was how little validation there was behind the techniques that I had taken for granted. Much of this was revealed in a 2009 report by the National Research Council, after a call by Congress for a study.

What happens to your data, research, and online identity after you die?
ScienceOnlineSeattle will explore this topic at our fall kickoff event. We will dig into the intricacies of data and social media archiving, intellectual property vs. the Cloud, and other issues at the nexus of science, online, and death.

Lack of access to scientific information has had serious implications both for the environment and human health. Joseph Davis, director of the Society for Environmental Journalist’s WatchDog Project, will highlight some recent examples where inadequate access to scientific information had serious consequences. Daniel Schuman, policy counsel at the Sunlight Foundation, will then discuss the latest attempts to regulate FOIA to restrict access to information and the impact that would have on science. After two short presentations, both speakers will answer questions from the audience in a moderated discussion.

Conference Call: Introduction to the Center for Science and Democracy

September 24th, 2012

4:00-4:30pm

Join us for a short conference call to meet the new director of UCS’s Center for Science and Democracy, Dr. Andrew Rosenberg. Dr. Rosenberg will discuss a strategic vision for the center and provide important background information for the next day’s symposium.

Keynote ConversationThe Honorable John Edward Porter, Research!America chair and former member of the U.S. Congress from Illinois, and Andrew Rosenberg, Center for Science and Democracy director, will discuss obstacles that prevent scientific information getting to policymakers, such as declining government resources for research, political interference in science and how that impacts the quality of information and how it is received, and the declining respect for science in Congress.

First Discussion Panel

Longtime journalist and news executive Ted Illiff, who has worked for CNN, USA Today, the Voice of America and Radio Free Europe, will moderate a discussion on citizen access to scientific information with the following panelists:

Katherine McFate, president and CEO of OMBWatch

Dan Vergano, reporter for USA Today

Curtis Brainard, staff writer for Columbia Journalism Review

Lisa Swirsky, senior policy analyst, health, Consumers Union

Second Discussion Panel

UCS Senior Scientist and Science Policy Fellow Francesca Grifo will moderate a discussion on how agencies can improve access to scientific information with panelists:

Inez Tenenbaum, chairman of the Consumer Product Safety Commission

Jane Lubchenco, administrator of the National Oceanic and Atmospheric Administration

Gina McCarthy, assistant administrator for EPA’s Office of Air and Radiation

Miriam Nisbet (invited), director of the Office of Government Information Services at the National Archives and Records Administration

Closing Remarks

Representative Ed Markey (D-MA) will discuss what happens when Congress fails to get the information it needs and how the right information can guide civil discussion and help create bipartisan policies that address pressing problems.

Recently in Britain, renewed talk of banned legislation regarding advances in an in vitro fertilization (IVF) technique has commenced. The controversial procedures would save children from inheriting certain genetic diseases but would also result in a child with three genetic parents and the destruction of a fertilized egg. The new IVF techniques obviously raise ethical and legal concerns, but should Britain pass this legislation they would be the first in the world to test these procedures in humans.

Mitochondrial DNA (mtDNA) is inherited from the mother and is the source of numerous devastating neuromuscular and neurodegenerative disease. Mutations in mtDNA passed on from mother to child are responsible for diseases such as muscular dystrophy, diabetes mellitus, deafness, and myoclonic epilepsy and affect around 1 in 5000 people. Now Britain has initiated steps towards clinical trials investigating a break through IVF technique that combines the nuclear DNA of the mother with mutation-free mtDNA from a donor egg.

UK’s Human Fertilization and Embryology Authority (HFEA) announced on January 19th a public dialogue regarding this emerging IVF technique in order to gauge public opinion of the possible use in a clinical setting. The Secretary of State of Health together with the Secretary of State of Business, Innovation, and Skills jointly asked HEFA to form this task force, a necessary first step to bringing this potentially life-saving technique to clinical trials. The public dialogue will begin later this year and be guided and overseen by a panel of experts. Additionally, the biomedical charity Welcome Trust has promised funds for preclinical safety experiments and the Nutffield Council on Bioethics has started an independent review. Here seems to be a perfect case where scientists, government, and policy experts are working together instead of just talking past or at each other.

There are two procedures currently under development: pronuclear transfer and maternal spindle transfer. In the first an egg with mutated mtDNA is fertilized in vitro, then the resulting pronucelus is removed and transferred to a donor egg that has had its pronucleus removed. The second technique involves chromosomes (DNA) taken from an unfertilized egg with mutated mtDNA being added to an unfertilized donor egg lacking a nucleus, then fertilization occurs in vitro. Pronuclear transfer has been successfully preformed on defective human eggs and maternal spindle transfer has been used to produce two healthy rhesus monkeys. Additionally, HEFA released a review in early 2011 finding the techniques not unsafe, although they did determine numerous additional studies would be required prior to beginning clinical trials.

These proposed IVF techniques, techniques that would produce children with three genetic parents, raise many important legal and ethical questions and issues. In the US federal funds cannot be used for research involving human embryos. Additionally, these procedures were banned by the British government in 2008 for safety, ethical, and research related reasons. But importantly, legislation was also put in place for a streamlined mechanism to legalize the techniques should scientific advances be made. Now, based on recent technical advances the British government has decided to take another look at the legislative ban. Chair of HFEA, Lisa Jardine, said in a recent press release, “This is an issue of great importance to families affected by mitochondria disease and it is also one of enormous public interest. The decision about whether this research technique should be made available to treat patients is one for the Secretary of State and, ultimately, Parliament. We will work hard to stimulate a rich and varied public debate, to help him make an informed decision.”

Last month was a Science on Tap talk I helped put together dealing with how animals are used as part of drug development, titled “Drug Safety and Animal Research – No Safe Alternatives” The speaker was a veterinarian working for SNBL, a company that is involved in the testing the safety of new drugs.

The main focus of her talk looked at things in a broader perspective than just how animals are used, and she spent a lot of time going through history of regulations needed to show the benefits of medicine before it is given to public. This was an effective way to make it clear why we use animals for the things we do. It’s easy to take for granted the relative assurance we have when we get a prescription filled that the drugs we take will do what they are supposed to and have minimal danger associated with it. It was just a little less than 40 years ago when regulations were added to require evidence of the effectiveness of a new drug before it could be marketed. While this process isn’t perfect, we’ve derived a lot of benefit from these kinds of requirements.

With that context it’s a little clearer to see the value of having animals available to tests these drugs prior to making them available to people. While we can learn some things from cell culture or other simple systems, we ultimately need an actual living organism to learn some of the affects the drug will have. It seems much more reasonable to rely an animal models from some of this than it would be to have to wait until patients start taking the drugs to learn about adverse effects.

Specifically looking at how animals are used, I think the speaker made a couple of points of very good points. First she made it very clear how the ultimate motivation of her work is to ensure the drugs that are being offered will be safe for whoever is taking them, both human and animal (and used a few good examples of how animals benefit from this work too, which is often overlooked). The use of animals in the testing is necessary part of this process, and one that would be avoided if it could be. A second important point was that if we want to know if something is having an adverse effect, then it is important that the animals that are being used in the test would be otherwise healthy. With this being the case the testers have a strong motivation to treat their subjects well, even if for nothing other than their own benefit.

Overall, I thought this was a good overview of this part of the drug development process, which many people may not be familiar with. I’m happy I had to chance to work with the Science on Tap folks to put it together, and hope FOSEP can work with them for more events.

This is shaping up to be a busy week with federal budget issues, with the 2012 budget being put together, and next week’s deadline for the deficit reduction supercommittee to come to a consensus about how to find a way to cut the budget by $1.5 trillion. Science has had some good coverage of how this is going to relate to science spending both in the News Focus section last week’s issue and on the ScienceInsider blog.

Things are even more difficult for science in fields that are more politically controversial. The department of Energy is facing cuts in both developing green energy and to the Advanced Research Projects Agency-Energy (ARPA-E), which have been criticized by Republicans as focusing too much on work that could be accomplished by the private sector. The recommendations to the deficit panel instead suggested the Office of Science be the focus of the DOE due to the more basic research being done through that office. Similar political controversy seems to have cost NOAA funding for a unified Climate Service program, though it did get an increase in funding for new satellites. This increase is smaller than was requested and may result in gaps in data collection and cuts to other NOAA programs.

While some areas of science seems to have come off a less worse off than other parts of the Federal government, funding will remain tight, and likely to be even tighter if more general cuts kick in without a deficit reduction agreement.

One comment I’ve heard frequently in discussions about transgenic plants is how the description “genetically modified” is a misnomer given how much we’ve modified the genetics through traditional breeding. Some proposed changes to how the EPA may regulate the use of this technology serve as a good example of how the distinction between old and new methods of modification may not be that important.

These proposed changes would relax the restrictions on some classes of crops that have been modified. One group called “cisgenic” modification would involve the transfer of gene between plants that can naturally interbreed. The example that introduced this concept was the American chestnut which is sensitive to a blight, while the related Chinese chestnut has developed resistance. It may be possible to cross these two plants to provide resistance in the American plants, but this would involve all the messiness of trying to get the right chromosomes into the new plants and hoping other undesirable traits don’t come along for the ride. On the other hand if we knew exactly which genes are responsible we could isolate them and transfer the genes, without having to worry about other genes interacting in unwanted or unexpected ways. According to the article, Charles Maynard and his group at the State University of New York is possibly close to identifying the genes responsible, getting us closer to being able to use the technology in such a way.

Alternatively, intragenic (inside the gene) modifications can be done that remove parts of DNA to change expression of traits, but wouldn’t need to have any new DNA being inserted.

However modifying the DNA in a lab instead of the field by crosses would mean these crops would have to go through the additional regulatory processes as transgenic organisms that have foreign DNA inserted into the genome. The proposed changes would allow cisgenic and possibly intragenic modification to bypass some of the requirements that transgenic crops have to go through. Not too surprisingly this has met resistance from those who think these kinds of plants should be more regulated rather than less. But it has also been opposed by people in support transgenic crops who think the change would create an artificial distinction based on the source of a gene, which really says very little about any actual effects of the changes that have been made. That this is an issue is a good demonstration of how the current regulatory system seems more focused on technology being used rather than actual properties of these plants.